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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Algin-X™ Ultra DECA™ - D00261E8101

Algin-X™ Ultra Alginate Alternative Impression Material, Fast Set, 2 (380ml) DECA™ Cartridge Standard Pack
DENTSPLY INTERNATIONAL INC.
61E810
In Commercial Distribution

  • D00261E81082 ()
  • D00261E8101 ()
  • D00261E8100 ()

  • 2 Cartridges (380ml each), 20 Dynamic Mixing Tips, 1 Bayonet Locking Ring
  • Total Volume: 380 Milliliter
61E810

  • Silicone dental impression material

Algin-X™ Ultra Alginate Alternative - D00261E8001

Algin-X™ Ultra Alginate Alternative Impression Material, Fast Set, 4 (50ml) Cartridge Refill
DENTSPLY INTERNATIONAL INC.
61E800
In Commercial Distribution

  • D00261E80082 ()
  • D00261E8001 ()
  • D00261E8000 ()

  • Total Volume: 50 Milliliter
  • 4 Algin-X™ Ultra Cartridges (50mL each) and 6 Mixing Tips
61E800

  • Silicone dental impression material

Calm-it™ Desensitizer - D00261A1001

Calm-it™ Unit Dose Sample
DENTSPLY INTERNATIONAL INC.
61A100
Not in Commercial Distribution

  • D00261A1001 ()

  • 1 Calm-it™ Desensitizer Unit Dose
61A100

  • Dental cavity varnish

Regisil® Rigid Super Fast Set Cartridge System - D0026194251

Regisil® Rigid Super Fast Set VPS Bite Reg Material (Purple), Cartridge System Refill Package
DENTSPLY INTERNATIONAL INC.
619425
In Commercial Distribution

  • D00261942582 ()
  • D0026194251 ()
  • D0026194250 ()

  • Total Volume: 50 Milliliter
  • 4 Cartridges (50mL each), 12 Mixing Tips
619425

  • Silicone dental impression material

FluoroCore® 2+ Dual Cure Core Build-up Material + Fast Endodontic Post Cement - D0026126001

FluoroCore® 2+ Introductory Kit
DENTSPLY INTERNATIONAL INC.
612600
In Commercial Distribution

  • D0026126001 ()
612600

  • Dental composite resin

Calibra® Abutment - D0026077010

Calibra® Abutment Resin Cement Sample
DENTSPLY INTERNATIONAL INC.
607701
In Commercial Distribution

  • D0026077010 ()

  • 1 Syringe (2g), 10 Mix Tips
607701

  • Dental composite resin

Calibra® Universal Self-Adhesive Resin Cement - D0026074071

Calibra® Universal Dual Cure Automix Syringe Refill Package
DENTSPLY INTERNATIONAL INC.
607407
In Commercial Distribution

  • D0026074071 ()
  • D0026074070 ()

  • 2 Syringes (4.5g) each and 20 Mixing Tips
  • Weight: 4.5 Gram
607407

  • Dental composite resin

Calibra® Universal Self-Adhesive Resin Cement - D0026074061

Calibra® Universal Cement Dual Cure Automix Syringe Refill Package, Opaque, 2 syringe (4.5g)
DENTSPLY INTERNATIONAL INC.
607406
In Commercial Distribution

  • D0026074061 ()
  • D0026074060 ()

  • Weight: 4.5 Gram
  • 2 Dual Cure AutoMix Syringes (4.5g) - Opaque - and 20 Mixing Tips
607406

  • Dental composite resin

Calibra® Universal Self-Adhesive Resin Cement - D0026074051

Calibra® Universal Cement Dual Cure Automix Syringe Refill Package, Translucent, 2 syringe (4.5g)
DENTSPLY INTERNATIONAL INC.
607405
In Commercial Distribution

  • D0026074051 ()
  • D0026074050 ()

  • 2 Dual Cure AutoMix Syringes (4.5g) - Translucent - and 20 Mixing Tips
  • Weight: 4.5 Gram
607405

  • Dental composite resin

Calibra® Universal+ Versatile Resin Cement - D002607403NA1

Calibra® Universal+ Syringe Refill - Medium Shade
DENTSPLY INTERNATIONAL INC.
607403NA
In Commercial Distribution

  • D002607403NA0 ()
  • D002607403NA1 ()

  • 2 Syringes (4.5g each); 20 Mixing Tips
607403NA

  • Dental composite resin
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